Geniculate Artery Embolization for Treatment of Osteoarthritis

Not Applicable

Completed

Conditions: Osteoarthritis

Interventions: Procedure: Transcatheter arterial embolization
Device: Embozene™ Microspheres

Registration Number: NCT04379700

Lead Sponsor: NYU Langone Health

Brief Summary: Single-arm, single-center, no sham or placebo, prospective pilot trial designed to evaluate the feasibility and safety of transcatheter arterial embolization in patients with mild to moderate radiographic knee OA. Eligible participants will receive geniculate artery embolization using Embozene™ Color-Advanced Microspheres. Patients will be followed up for a total of 12 months.

Detailed Description: The current study seeks to determine whether transcatheter arterial embolization of abnormal neovasculature arising from the genicular arterial branches is safe and effective in the treatment of mild-to-moderate knee OA.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 38

Inclusion Criteria

30-80 years of age of any gender;
Kellgren-Lawrence Grade 2, 3, or 4 (in select subjects who have no bony deformity) knee OA on most recent knee radiograph obtained within 6 months of screening visit;
Knee pain resistant to conservative treatment for at least 3 months (anti- inflammatory drugs, acetaminophen, physical therapy, muscle strengthening, or intra- articular injection of hyaluronic acid and/or steroids);
Moderate to severe knee pain: pain VAS ≥ 40 mm with 0 representing 'no pain' and 100 'the worst pain imaginable. If both knees meet inclusion criteria, the one with a higher VAS score will be chosen for the study (i.e., target knee).
Willing, able, and mentally competent to provide informed consent and complete study questionnaires in English. The Study questionnaire is validated in English.

Exclusion Criteria

Active systemic or local knee infection;
Active malignancy;
Life expectancy less than 12 months;
Prior ipsilateral knee surgery (within 3 years of baseline visit), arthroscopic surgery (within 6 months of baseline), total or partial knee replacement regardless of timing;
Ipsilateral knee intra-articular injection in the last 3 months;
Rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus;
Pregnant during the study period;
Renal dysfunction as defined by serum creatinine >1.6 dl/mg or eGFR <60 on blood tests obtained within 30 days of procedure;
Body weight greater than 200 Kg;
Uncorrectable coagulopathy (platelet count < 50,000, international normalized ratio >1.5 within 30 days of procedure;
Known history of contrast allergy resulting in anaphylaxis;
Known significant arterial atherosclerosis that would limit selective angiography and/or lower extremity symptoms thought to be secondary to arterial vascular disease (eg claudication, ischemic rest pain);
Post-traumatic knee (if trauma occurred within 12 months of baseline or was associated with fractures);
Known avascular necrosis in the target knee;
Contraindications to MRI such as such as claustrophobia, metallic fragment/implants, pacemaker.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Embolization Group	Transcatheter arterial embolization	23 participants who are aged between 30 to 75 years old, with grade 2 or 3 knee OA on the most recent knee radiographs obtained within 6 months of intervention. Each individual participant will be enrolled for approximately 13 months to complete all study visits from the initial screening visit to last follow up at 12-months post intervention.
Embolization Group	Embozene™ Microspheres	23 participants who are aged between 30 to 75 years old, with grade 2 or 3 knee OA on the most recent knee radiographs obtained within 6 months of intervention. Each individual participant will be enrolled for approximately 13 months to complete all study visits from the initial screening visit to last follow up at 12-months post intervention.

Primary Outcome Measures

Name	Time	Method
Percentage Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Score	Baseline, Month 3	The WOMAC questionnaire includes 24 questions on daily activities. The Pain Score subsection includes five questions regarding pain (pain during walking, stair climbing, nocturnal, rest, weight bearing); each question is scored on a Likert scale as follow: 0 for no pain, 1 for mild, 2 for moderate, 3 for severe, and 4 for extreme pain. The total score is the sum of responses and ranges from 0-20; higher scores indicate greater pain.

Secondary Outcome Measures

Name	Time	Method
Change in WOMAC - Pain Score	Baseline, Month 12	The WOMAC questionnaire includes 24 questions on daily activities. The Pain Score subsection includes five questions regarding pain (pain during walking, stair climbing, nocturnal, rest, weight bearing); each question is scored on a Likert scale as follow: 0 for no pain, 1 for mild, 2 for moderate, 3 for severe, and 4 for extreme pain. The total score is the sum of responses and ranges from 0-20; higher scores indicate greater pain.
Change in Visual Analogue Scale (VAS) Rating of Knee Pain	Baseline, Month 1	The electronic VAS is a horizontal line with no markings on the scale except "No pain" on the left (score: 0 mm) and "worst possible pain" on the right end of the scale (score: 100 mm). Subjects mark the VAS to indicate their current pain level, with 0 mm representing "No pain" and 100 mm representing "worst possible pain".
Change in VAS Rating of Knee Pain	Baseline, Month 12	The electronic VAS is a horizontal line with no markings on the scale except "No pain" on the left (score: 0 mm) and "worst possible pain" on the right end of the scale (score: 100 mm). Subjects mark the VAS to indicate their current pain level, with 0 mm representing "No pain" and 100 mm representing "worst possible pain".
Change in WOMAC - Stiffness Score	Baseline, Month 12	The WOMAC - Stiffness Score is calculated using the Knee Injury and Osteoarthritis Outcome Score (KOOS) extension to the WOMAC score. The Stiffness Score comprises 2 items related to knee stiffness; both items are rated on a Likert scale from 0-4; the total score is the sum of responses and ranges from 0-8. Higher scores indicate more severe knee stiffness.
Change in WOMAC - Physical Function Score	Baseline, Month 12	The WOMAC - Physical Function Score is calculated using the KOOS extension to the WOMAC score. The Physical Function Score comprises 17 items related to function in daily life and in sports/recreation; all items are rated on a Likert scale from 0-4; the total score is the sum of responses and ranges from 0-68. Higher scores indicate more severe dehabilitation.
Change in WOMAC - Overall Score	Baseline, Month 12	The WOMAC questionnaire includes 24 questions on daily activities. All items are rated on a scale from 0-4. The total score is the sum of responses and ranges from 0-96. A higher overall WOMAC score indicates greater pain, stiffness, and functional limitations.
Change in Quality of Life Assessed Via 5-level EQ-5D Version (EQ-5D-5L)	Baseline, Month 1	Quality of life reported by the patient measured using the 6-item EQ-5D-5L measure. EQ-5D-5L states are converted into an index value; index values range from full health (1) to no health (-0.109).
Change in Quality of Life Assessed Via EQ-5D-5L	Baseline, Month 12	Quality of life reported by the patient measured using the 6-item EQ-5D-5L measure. EQ-5D-5L states are converted into an index value; index values range from full health (1) to no health (-0.109).